Incorrect ectopic pregnancy diagnoses led to abortions: study

Canadian researchers have documented a string of cases in which women were misdiagnosed with ectopic pregnancies, then given a powerful drug that led to miscarriage, abortion or the birth of severely deformed babies.

The blunder – causing “significant emotional suffering” – is likely more common than it appears, researchers at Toronto’s Sick Kids Hospital say, noting that use of the drug, methotrexate, has soared in recent years. Such misdiagnoses are seldom reported to authorities now, likely in part because of physicians’ fear of legal problems, said their study, just published in the American Journal of Obstetrics and Gynecology.

The researchers catalogue eight recent cases, in both Canada and the U.S.

In some cases, they say, emergency-department doctors with limited training in analyzing ultrasound images may be mistakenly identifying healthy pregnancies as ectopic, where the embryo develops outside the womb.

The authors argue that the diagnosis should be made only after a confirmatory ultrasound and careful consideration. The also urge that a non-judgmental system be established to encourage more reporting of such cases.

“They all ended up in dire outcomes, they were all desired pregnancies,” Dr. Yaron Finkelstein, an emergency doctor and toxicologist at Sick Kids, said about the study he spearheaded. “Our wish was to highlight and raise awareness of this phenomenon … There is not a lot of incentives for clinicians to report these cases.”

He stressed that his own expertise is not in obstetrics and gynecology, but said he hoped the study would underline the possibility for error and its disastrous consequences.

One similar case earned an Ontario doctor a rebuke from medical regulators recently.

A spokeswoman for the Society of Obstetrics and Gynecology of Canada said the association would not comment on the Sick Kids research until it had reviewed it in detail.

An ectopic pregnancy is one where the embryo develops outside the uterus. Left alone, it can continue to grow, then burst and cause life-threatening complications for the woman. For that reason, the diagnosis is often followed by a surgery to end the pregnancy or administration of a drug like methotrexate, which is injected by a doctor.

In fact, U.S. statistics suggest use of the medication – seen as a safer alternative to surgical abortion – climbed three-fold between 2002 and 2007, the study notes.

Dr. Finkelstein said he and his colleagues decided to look into the problem in more depth after being asked for advice by an Ontario doctor who had wrongly diagnosed an ectopic pregancy, leading to an unnecessary miscarriage.

The Motherisk team at Sick Kids – which researches and provides education on threats to pregnancy – catalogued reports of eight such cases in recent years, three made to the Toronto hospital and five to similar centres at the University of California, San Diego, and in Hartford, Conn.

None of the cases resulted in a healthy birth. Two continued to delivery, one of them born “severely malformed,” with cardiac disease, a missing kidney and skeletal deformities, among other problems The baby required multiple operations and had a cardiac arrest shortly after being delivered.

Another baby was still-born after 30 weeks, with similar deformities.

Three of the women miscarried, and three others had abortions on the advice of their doctors. In two of those cases, the physician made the recommendation based on the legal repercussions of possible adverse effects and the resulting “tremendous costs and suffering,” the researchers wrote.

“All eight women reported significant emotional suffering as a result of misdiagnosis and dire outcomes,” the article said.

While the reports of such mistakes are uncommon, the authors say there is evidence it is a broader problem. Not only has use of methotrexate boomed, but some research indicates that the initial diagnosis of ectopic pregnancy ends up being wrong in 40% of cases.

“This may be a serious public health issue,” the study suggested. “It is conceivable that this phenomenon may not be rare, and is likely under-reported in current literature, and … unappreciated by regulatory agencies and professional societies.”

One similar case did end up before the Ontario College of Physicians and Surgeons, however, involving a doctor who prescribed a different medical-abortion drug to a woman misdiagnosed with another type of failed pregnancy – blighted ovum. The patient sought out a second opinion, eventually discovering the fetus was developing healthily. She never took the drug, but filed a complaint against the physician. In a decision upheld on appeal last year, the college chastized the obstetrician-gynecologist over her handling of the situation.